BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, LP

    MDR report key: 21157467 · Received January 15, 2025

    Report

    Report Number
    21157467
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    December 18, 2024
    Report Date
    January 2, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    OPENING A PACK FOR THE CASE WE WERE ABOUT TO PERFORM. A SMALL BLACK CRUNCHY PARTICLE WAS FOUND IN THE BOTTOM OF THE SMALL PLASTIC BOWL IN THE PACK. THE PACK WAS AN OR PROCEDURE PACK LF. THE CENTRAL SUPPLY (CS), WAS NOTIFIED, THE OLD WAS DISCARDED AND A NEW WAS ORDERED FROM SUPPLY CHAIN. AFTER THE DISCOVERY, ALL WENT WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932192 MEDLINE INDUSTRIES, LP GENERAL SURGERY TRAY LRO MEDLINE INDUSTRIES, LP DYNJ47947G 24IMF899

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown